Scalable Clinical Oversight of Large Language Models Via Uncertainty Triangulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

This prospective, multi-reader, randomized crossover trial evaluates SCOUT (Scalable Clinical Oversight via Uncertainty Triangulation), a model-agnostic meta-verification framework that selectively defers unreliable large language model (LLM) predictions to clinicians by triangulating three orthogonal uncertainty signals: model heterogeneity, stochastic inconsistency, and reasoning critique. The trial assesses whether SCOUT-assisted review can reduce physician review time compared with standard manual review of AI-generated diagnoses while maintaining non-inferior diagnostic accuracy in coronary heart disease (CHD) subtyping.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Board-certified or in-training cardiologists at Fuwai Hospital

Spanning three experience strata: junior residents, senior residents, attending physicians

Disqualifiers

Clinicians involved in the development or optimization of the SCOUT framework

Clinicians involved in the gold-standard adjudication process

Trial design

Design model

Crossover

Treatments tested in this trial

  • SCOUT-Assisted Review Workflow

    Diagnostic test

    SCOUT-Assisted Review (Intervention Arm): Physicians review 56 cases processed through the SCOUT framework. For cases classified as low-uncertainty (D(x)=0), the AI prediction is auto-accepted without physician review. For high-uncertainty cases (D(x)=1), the physician reviews the case with access to the main model's chain-of-thought reasoning and the meta-verification audit results. The main model is DeepSeek-V3.1 with chain-of-thought prompting.

  • Standard Manual Review Workflow

    Diagnostic test

    Physicians perform a full manual review of 54 cases using raw medical records with access to the AI model's predictions and reasoning, but without SCOUT uncertainty stratification or selective deferral.

Treatment groups

7 Participants
are divided into 2 treatment groups
Group A: Control (Standard Manual Review)Active comparator 1 intervention
Group B: Experimental (SCOUT-Assisted Review)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean physician review time per case (minutes)

Mean time spent by each clinician reviewing and rendering a diagnostic decision per case under each arm. Measured in minutes.

Time frame
Through study completion, an average of 2 hours.

Secondary outcomes

1

Diagnostic accuracy (%)

Proportion of correct CHD subtype classifications (STEMI, NSTEMI, unstable angina, chronic coronary syndromes) under each arm.

Time frame
Through study completion, an average of 2 hours.
2

Computational Return on Investment (ROI)

Ratio of physician time savings (valued at standardized minute-wages from Sanming healthcare reform benchmarks) to computational cost of SCOUT inference, stratified by clinician seniority level.

Time frame
Through study completion, an average of 2 hours.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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